U.S. patent application number 15/573591 was filed with the patent office on 2019-07-11 for container for a medical liquid.
The applicant listed for this patent is Fresenius Kabi Deutschland GmbH. Invention is credited to Torsten Brandenburger, Christian Frensch, Ismael Rahimy.
Application Number | 20190209435 15/573591 |
Document ID | / |
Family ID | 53174928 |
Filed Date | 2019-07-11 |
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United States Patent
Application |
20190209435 |
Kind Code |
A1 |
Brandenburger; Torsten ; et
al. |
July 11, 2019 |
CONTAINER FOR A MEDICAL LIQUID
Abstract
A container for a medical liquid, comprising a connection piece
via which a medical liquid can be pumped into or out of the
container, an attachment part which can be attached to the
connection piece and connected to a pump device to pump a medical
liquid or out of the container, and a sealing element for sealing a
passage between the connection piece and the attachment part. The
sealing element has a slot opening which is closed against a liquid
flow when the pump device is not attached to the attachment part
and which is open when the pump device is attached to the
attachment part such that a medical liquid can be pumped through
the slot opening. The attachment part has a connection portion with
an opening into which the connection piece can be inserted along an
insertion direction in order to connect to the attachment part.
Inventors: |
Brandenburger; Torsten;
(Reichelsheim, DE) ; Rahimy; Ismael; (Friedberg,
DE) ; Frensch; Christian; (Hofheim, DE) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Fresenius Kabi Deutschland GmbH |
Bad Homburg |
|
DE |
|
|
Family ID: |
53174928 |
Appl. No.: |
15/573591 |
Filed: |
May 11, 2016 |
PCT Filed: |
May 11, 2016 |
PCT NO: |
PCT/EP2016/060539 |
371 Date: |
November 13, 2017 |
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 39/045 20130101;
A61J 1/2048 20150501; A61M 39/20 20130101; A61J 1/2044 20150501;
A61J 1/2096 20130101; A61M 39/26 20130101; A61M 2039/2426 20130101;
A61M 2039/1033 20130101; A61J 1/1412 20130101; A61M 2039/1072
20130101; A61M 2039/1061 20130101 |
International
Class: |
A61J 1/20 20060101
A61J001/20; A61J 1/14 20060101 A61J001/14; A61M 39/26 20060101
A61M039/26; A61M 39/20 20060101 A61M039/20 |
Foreign Application Data
Date |
Code |
Application Number |
May 13, 2015 |
EP |
15167619.4 |
Claims
1. A container for a medical liquid, having a connection piece by
means of which a medical liquid is conveyable into the container or
out of the container, an attachment part which is attachable to the
connection piece and is connectable to a conveying device for
conveying a medical liquid into the container or out of the
container, and a sealing element for sealing a transition between
the connection piece and the attachment part, wherein the sealing
element comprises a slot opening which, with the conveying device
not attached to the attachment part, is closed against a passage of
liquid and, as a result of attaching the conveying device to the
attachment part, is to be opened in such a manner that a medical
liquid is conveyable through the slot opening wherein the
attachment part comprises a connecting portion with an opening into
which the connection piece is insertable along an insertion
direction for connection to the attachment part and the opening
comprises a first receiving portion and a second receiving portion
which connects axially thereto along the insertion direction,
wherein, with the attachment part attached to the connection piece,
the first receiving portion receives a head of the connection piece
and the second receiving portion receives a portion of the sealing
element, wherein the first receiving portion comprises a first
diameter and the second receiving portion comprises a second
diameter, wherein the first diameter is smaller than the second
diameter and the sealing element, with the conveying device not
attached to the attachment part, is received in the second
receiving portion with radial play.
2. The container as claimed in claim 1, wherein the sealing element
is produced from a thermoplastic elastomer which comprises, in
particular, a Shore Hardness A of between 25 and 70, preferably of
between 30 and 60.
3. The container as claimed in claim 1, characterized in that
wherein the sealing element is produced from polyisoprene.
4. The container as claimed in claim 1 wherein the second diameter
of the second receiving portion is greater than the first diameter
of the first receiving portion by between 0.2 mm and 1.5 mm.
5. The container as claimed in claim 1 wherein the first receiving
portion and the second receiving portion each comprise an inner
toothing which extends around the insertion direction.
6. The container as claimed in claim 1 wherein the sealing element
comprises a body, which, with the attachment part attached to the
connection piece is received in a clamping manner between the
connection piece and the attachment part, and a sealing head which
connects to the body and in which the slot opening is realized.
7. The container as claimed in preceding claim 6, wherein the body
of the sealing element comprises an outer diameter of between 6 mm
and 10 mm and the sealing head which connects to the body comprises
an outer diameter of between 4 mm and 7 mm.
8. The container as claimed claim 6 wherein the sealing head is
realized in a flat, convex or concave manner on a side remote from
the body.
9. The container as claimed in claim 6, wherein the body of the
sealing element comprises a, preferably cylindrical, bore with a,
preferably constant, diameter which, with the conveying device not
attached to the attachment part, is closed by the sealing head
against a passage of liquid and/or in that the sealing element
comprises a positive locking element which projects radially from
the body for holding the sealing element on the attachment
part.
10. The container as claimed in claim 1 wherein the attachment part
comprises a threaded portion with at least one thread for producing
a threaded connection to the conveying device and a break-off piece
which is connected to the threaded portion, wherein the break-off
piece closes an opening of the threaded portion in a state
connected to the threaded portion and is removable from the
threaded portion to release the opening.
11. The container as claimed in claim 10, wherein the threaded
portion and the break-off piece are realized in one piece, wherein
a predetermined breaking point for breaking-off the break-off piece
from the threaded portion is arranged between the threaded portion
and the break-off piece.
12. A connector for a container for a medical liquid as claimed in
claim 1, having a connection piece, through which a medical liquid
is conveyable, an attachment part which is attachable to the
connection piece and is connectable to a conveying device for
conveying a medical liquid through the connection piece, and a
sealing element for sealing a transition between the connection
piece and the attachment part, wherein the sealing element
comprises a slot opening which, with the conveying device not
attached to the attachment part, is closed against a passage of
liquid and, as a result of attaching the conveying device to the
attachment part, is to be opened in such a manner that a medical
liquid is conveyable through the slot opening wherein the
attachment part comprises a connecting portion with an opening into
which the connection piece is insertable along an insertion
direction for connection to the attachment part and the opening
comprises a first receiving portion and a second receiving portion
which connects axially thereto along the insertion direction,
wherein, with the attachment part attached to the connection piece,
the first receiving portion receives a head of the connection piece
and the second receiving portion receives a portion of the sealing
element wherein the first receiving portion comprises a first
diameter and the second receiving portion comprises a second
diameter, wherein the first diameter is smaller than the second
diameter and the sealing element, with the conveying device not
attached to the attachment part, is received in the second
receiving portion with radial play.
13. A sealing element for a container as claimed in claim 1,
wherein the sealing element comprises a body with an outer diameter
of between 6 mm and 10 mm and a sealing head which connects to the
body with an outer diameter of between 4 mm and 7 mm.
14. An arrangement having a container as claimed in claim 1, having
a connector as claimed in claim 12, which is inserted in a
connector with radial play, and a conveying device which comprises
a connecting piece for the attachment to the attachment piece,
wherein, with the conveying device attached to the attachment part,
the connecting piece penetrates the slot opening of the sealing
element.
15. The arrangement as claimed in claim 14, wherein the conveying
device, in the state attached to the attachment part, extends
through the slot opening of the sealing element in such a manner
that at least 80%, of an opening cross section in the conveying
device, through which the liquid is transported, is exposed.
16. A sealing element for a connector as claimed in claim 12
wherein the sealing element comprises a body with an outer diameter
of between 6 mm and 10 mm and a sealing head which connects to the
body with an outer diameter of between 4 mm and 7 mm.
17. An arrangement having a container having a sealing element as
claimed in claim 13, which is inserted in a connector with radial
play, and a conveying device which comprises a connecting piece for
the attachment to the attachment piece, wherein, with the conveying
device attached to the attachment part, the connecting piece
penetrates the slot opening of the sealing element.
Description
[0001] The invention relates to a container for a medical liquid
according to the preamble of claim 1.
[0002] A container of this type includes one or multiple connection
pieces, by means of which a medical liquid can be conveyed into the
container or out of the container. An attachment part, which can be
connected to a conveying device, e.g. a syringe, for conveying a
medical liquid into the container or out of the container, can be
attached to at least one of said connection pieces. A sealing
element seals a transition between the connection piece and the
attachment part, the sealing element generally comprising a slot
opening which, with the conveying device not attached to the
attachment part, is closed against a passage of liquid and, as a
result of attaching the conveying device to the attachment part,
can be opened in such a manner that a medical liquid can be
conveyed through the slot opening.
[0003] Such a container can be configured, for example, as a
flexible pouch or also as an ampoule or another bottle
container.
[0004] In the case of a connector disclosed in WO 2005/037362 A1, a
self-sealing diaphragm is inserted into a duct-shaped recess of a
connection part for a packaging containing a medical liquid. The
duct-shaped recess is closed by a break-off part which can be
broken off from the connection part to release the duct-shaped
recess such that a syringe can be attached to the connection part
with the connecting piece. As a result of attaching the syringe to
the connection part, the diaphragm is able to be opened such that a
liquid can be conveyed into a container or out of the container. WO
2015/007703 A1 describes a corresponding ampoule for a medical
liquid.
[0005] In the case of a connector disclosed in WO 2010/034470 A1, a
hollow body with a tip is arranged on one side of a diaphragm which
is remote from a syringe to be attached to the diaphragm. When the
syringe is attached to the connector, the syringe presses the
diaphragm onto the tip of the hollow body such that the syringe
engages the hollow body and consequently a flow through the
diaphragm is made possible.
[0006] WO 2013/017698 A1 describes a needle-free connector. Said
needle-free connector includes a valve body with a first and a
second opening. A hollow elastic diaphragm is arranged in the valve
body. The diaphragm has a first and a second end. The diaphragm
comprises a side wall which connects the first end to the second
end. The side wall of the diaphragm abuts against an inner surface
of the valve body.
[0007] It is the object of the present invention to provide a
container with a connection piece and an attachment part which is
attachable thereto, where a large flow, in particular with a small
amount of effort expended, can be obtained for conveying a medical
liquid into the container or out of the container.
[0008] Said object is achieved by the subject matter with the
features of claim 1.
[0009] Claim 1 describes a container for a medical liquid, having a
connection piece, by means of which a medical liquid is conveyable
into the container or out of the container, an attachment part
which is attachable to the connection piece and is connectable to a
conveying device for conveying a medical liquid into the container
or out of the container, and a sealing element for sealing a
transition between the connection piece and the attachment part,
wherein the sealing element comprises a slot opening which, with
the conveying device not attached to the attachment part, is closed
against a passage of liquid and, as a result of attaching the
conveying device to the attachment part, is to be opened in such a
manner that a medical liquid is conveyable through the slot
opening. The attachment part comprises a connecting portion with an
opening into which the connection piece is insertable along an
insertion direction (E) for connection to the attachment part. The
opening comprises a first receiving portion and a second receiving
portion which connects axially thereto along the insertion
direction (E), wherein, with the attachment part attached to the
connection piece, the first receiving portion receives a head of
the connection piece and the second receiving portion receives a
portion of the sealing element.
[0010] According to the invention, the first receiving portion
comprises a first diameter D1 and the second receiving portion
comprises a second diameter D2, wherein the first diameter D1 is
smaller than the second diameter D2 and the sealing element, with
the conveying device not attached to the attachment part, is
received in or on the second receiving portion with radial play.
This makes it possible for the sealing element to be able to be
inserted in the second receiving portion with play and
nevertheless, at the same time, to be able to be held in a clamping
manner between the connection part and the attachment part. Because
the sealing element is inserted with play in the second receiving
portion, when a conveying device is attached, in particular a
syringe, it can be deformed radially and consequently can be urged
aside by the conveying device such that the slot opening provided
in the sealing element can be opened in a reliable manner as the
sealing element is deformed and can be exposed, preferably
completely.
[0011] In one embodiment, it is provided in the case of the
container that the sealing element is produced from a thermoplastic
elastomer. In particular, the thermoplastic elastomer (TPE)
comprises, in this connection, a Shore Hardness A of between 25 and
70, preferably of between 50 and 60. The thermoplastic elastomer
preferably is or includes a TPE material of the styrene TPE
type.
[0012] The named Shore Hardness is a material characteristic for
thermoplastic elastomers which is fixed in standard DIN ISO 7619-1.
In a Shore Hardness test, a spring-loaded pin produced from
hardened steel is fitted onto a material to be tested and the
penetration depth into the material is tested. A high Shore
Hardness means that the material has a greater degree of hardness.
In general, the Shore Hardness is measured on a scale of between 0
and 100. The tip of the steel pin presses into the material at
Shore A or penetrates the material at Shore D. The depth of
impression/penetration is measured on a scale of 0-100. The steel
pin has either the geometry of a truncated cone (Shore A) or of a
needle tip (Shore D).
[0013] In the case of conventional containers, there can be the
problem of the sealing element, for example in the form of a
diaphragm, not opening completely when a conveying device, in
particular a syringe, is attached. This can make it necessary to
re-attach the conveying device or, however, can impair the flow
through the connection piece. An additional hollow body with a tip,
which is to support the opening of the diaphragm, is provided for
this purpose in the prior art. In the case of the connector
according to the invention, however, no additional hollow body is
provided. Whilst conventional sealing elements can be produced from
a comparatively soft material, the sealing element in one
embodiment is produced from a thermoplastic elastomer, preferably
with a comparatively high Shore Hardness. In an alternative
embodiment, the sealing element is produced from polyisoprene.
[0014] In one embodiment, the sealing element is provided in such a
manner that when a conveying device, in particular a syringe, is
attached to the attachment part, the sealing element can be
deformed sufficiently to open the slot opening and exposes a
sufficiently large flow opening. The conveying device, when it is
attached to the attachment piece, extends, preferably with a
connecting piece, through the slot opening of the sealing element
such that a flow between the conveying device and the container can
be effected unobstructed by the sealing element. In one embodiment,
at least 80%, preferably at least 90%, of the opening cross section
in the conveying device, through which the liquid is transported,
is exposed and consequently not covered by the seal. Preferably the
entire cross section of the opening in the conveying device,
through which the liquid is transported, is exposed.
[0015] For example, a higher degree of hardness of the sealing
element can enable an advantageous flow because the sealing element
with a higher degree of hardness--in particular compared to a
softer sealing element--can be deformed advantageously to open the
slot opening when the conveying device, in particular a connecting
piece of a syringe, is attached. In particular, the sealing element
can be urged aside radially without excessive deformation occurring
in the axial direction and, in particular, the sealing element
cannot stretch excessively in the axial direction when the
conveying device is attached.
[0016] According to the invention, the attachment part comprises a
connecting portion with an opening into which the connection piece
can be inserted along an insertion direction for connection to the
attachment part. As a result of inserting the connection piece into
the opening of the attachment part, the connection piece is
connected to the attachment part in a positive locking manner, the
sealing element resting in a clamping manner between the attachment
part and the connection piece and consequently being held in a
sealing manner between the attachment part and the connection
piece.
[0017] The basic form of the opening can be substantially
cylindrical. A first receiving portion is realized in the opening
in this connection, to which--when viewed along the insertion
direction--a second receiving portion is axially connected. If the
attachment part is attached to the connection piece, the first
receiving portion thus receives a head of the connection piece,
preferably in a positive locking manner, whilst a, for example,
rotationally symmetrical body of the sealing element rests in the
second receiving portion.
[0018] In this connection, the diameter of the first receiving
portion is smaller than that of the second receiving portion. This
makes it possible for the sealing element to be inserted with play
in the second receiving portion and nevertheless, at the same time,
to be able to be held in a clamping manner between the connection
part and the attachment part. Because the sealing element is
inserted with play in the second receiving portion, when a
conveying device is attached, in particular a syringe, it can be
deformed radially and consequently can be urged aside by the
conveying device such that the slot opening provided in the sealing
element can be opened in a reliable manner as the sealing element
is deformed.
[0019] The attachment part and the connection piece are connected
together in a positive locking manner by means of the first
receiving portion. In this connection, an inner toothing which
extends around the insertion direction can be provided on the first
receiving portion, said inner toothing, with the attachment part
attached to the connection piece, engages an assigned toothing on
the head of the connection piece in a positive locking manner such
that the attachment part and the connection piece are fixed with
respect to one another so as to be non-rotatable about the
insertion direction. Once the attachment part has been attached to
the connection piece, the attachment part and the connection piece
can consequently (no longer) be rotated with respect to one another
such that the attachment part is fixed on the connection piece.
[0020] In one embodiment, both the first receiving portion and the
second receiving portion comprise a toothing, for example in the
form of a circumferential inner toothing. The toothing of the first
receiving portion serves for the non-rotatable fixing on the head
of the connection piece. The toothing of the second receiving
portion serves for removing the attachment part from the mold in an
improved manner after the injection molding process during
production.
[0021] In an advantageous configuration, the sealing element
comprises a cylindrical body, which, when the attachment part is
attached to the connection part, is held in a clamping manner
between the connection piece and the attachment part, and a sealing
head which connects to the body and in which the slot opening is
realized. In this connection, the body can comprise a larger
diameter than the sealing head (when viewed radially to the
insertion direction). The sealing element is preferably configured
overall in a rotationally symmetrical manner with a cylindrical
body and a sealing head which connects thereto.
[0022] The sealing head is preferably realized in a flat manner on
a side remote from the body. This makes it possible, when a
conveying device, in particular a syringe, is attached to the
attachment part, for the sealing head to be able to be urged aside
in an advantageous manner as a result of inserting a connecting
piece of the conveying device into the slot opening such that, with
the conveying device attached completely to the attachment part,
the connecting piece penetrates the sealing head of the sealing
element and consequently a flow between the conveying device and
the container is not impaired by the sealing element.
[0023] However, it is also conceivable and possible for the sealing
head to be curved convexly outward or concavely inward on its side
remote from the body.
[0024] The body of the sealing element preferably comprises a,
preferably cylindrical or substantially cylindrical, bore which is
delimited axially by the sealing head and is preferably realized
with a constant diameter over its entire height (when viewed along
the insertion direction) or is tapered toward the sealing head. By
the, preferably cylindrical, bore being realized with a large
diameter--compared to a flow opening of a connecting piece of a
conveying device--it can be ensured that the sealing element does
not obstruct a flow with its body when the conveying device is
attached to the attachment part.
[0025] In order to facilitate the attaching of the attachment part
to the connection piece, a positive locking element, which
protrudes radially from the body, for example in the form of a
circumferential annulus, can be provided on the sealing element,
which positive locking element serves for the purpose of holding
the sealing element on the attachment part when it is inserted into
the opening of the attachment part. The mounting of the attachment
part on the connection piece can consequently be effected together
with the sealing element, which is inserted into the opening of the
attachment part, without particular provisions having to be made to
hold the sealing element in position with respect to the attachment
part.
[0026] In an advantageous configuration, the attachment part
comprises a threaded portion with at least one thread for producing
a threaded connection to a conveying device which is to be attached
to the attachment part. The threaded portion can provide, for
example, a Luer attachment, by means of which the closure part can
be connected in the manner of a so-called Luer lock to a conveying
device, for example a syringe. To this end, the conveying device
can comprise a connection element in the form of a union nut with
an internal thread which can be moved into threaded engagement with
the threaded portion such that the conveying device can be
releasably connected to the container by means of the threaded
portion.
[0027] A break-off piece which, in a state connected to the
threaded portion, closes an opening of the threaded portion and to
expose the opening can be removed, in particular manually broken
off, from the threaded portion, preferably connects to the threaded
portion--in an initial state prior to attaching a conveying device
to the attachment part. The attachment part is closed in its
initial state by means of the break-off piece such that the access
to the container, provided by means of the connection piece, is
securely sealed. To open it, the break-off piece can be removed, in
particular broken off, from the threaded portion, it being possible
to provide, to this end, a defined predetermined breaking point
between the break-off piece and the threaded portion, at which the
break-off piece can be separated in a defined manner from the
threaded portion. With the break-off piece broken off, the opening
of the threaded portion is then exposed such that a conveying
device can be attached to the attachment part for conveying a
liquid in or out. The interior of the attachment part, which is
closed by the break-off piece, is preferably already sterile in the
initial state in which the break-off piece has not yet been
removed.
[0028] A connector, in particular for an embodiment of the
previously described container, is also within the field of the
invention. The connector includes a connection piece, by means of
which a medical liquid is conveyable, an attachment part which is
connected to the connection piece, preferably by means of
attachment, and is connectable to a conveying device for conveying
a medical liquid through the connection piece, and a sealing
element for sealing a transition between the connection piece and
the attachment part. The sealing element comprises a slot opening
which, with the conveying device not attached to the attachment
part, is closed against a passage of liquid and, as a result of
attaching the conveying device to the attachment part, is to be
opened in such a manner that a medical liquid is conveyable through
the slot opening. The attachment part comprises a connecting
portion with an opening into which the connection piece is
insertable along an insertion direction (E) for connection to the
attachment part. The opening comprises a first receiving portion
and a second receiving portion which connects axially thereto along
the insertion direction (E). With the attachment part attached to
the connection piece, the first receiving portion receives a head
of the connection piece and the second receiving portion receives a
portion of the sealing element. The connector is characterized in
that the first receiving portion comprises a first diameter D1 and
the second receiving portion comprises a second diameter D2,
wherein the first diameter D1 is smaller than the second diameter
D2 and the sealing element, with the conveying device not attached
to the attachment part, is received in the second receiving portion
with radial play. In one configuration, the sealing element is
produced from a thermoplastic elastomer. For possible further
embodiments of the connector, reference is made to the previous
description.
[0029] In addition, a sealing element for an embodiment of the
previously described container and/or of the previously described
connector is also within the field of the invention. Said sealing
element is characterized in that it comprises a body with an outer
diameter of between 6 mm and 10 mm and a sealing head, which
connects to the body, with an outer diameter of between 4 mm and 7
mm. In one configuration, the sealing element is produced from a
thermoplastic elastomer. For possible further embodiments of the
sealing element, reference is made to the previous description.
[0030] In the case of an arrangement of a container according to
the previously described type and of a conveying device, the
conveying device can be attached to the attachment part, which is
connected to the connection piece, by way of a connecting piece. In
this connection, the connecting piece moves into contact with the
sealing element inside the attachment part and urges the sealing
element aside in such a manner that, with the conveying device
attached, the connecting piece penetrates the slot opening of the
sealing element, preferably completely, and consequently a flow
between the conveying device and the container is not impaired or
is not substantially impaired by the sealing element.
[0031] The sealing element can comprise, for example, an outer
diameter of between 6 mm and 10 mm, preferably of between 7 mm and
9 mm, for example of 8 mm, corresponding to the outer diameter of
the body of the sealing element.
[0032] The diameter of the sealing head of the sealing body which
connects to the body can, in contrast, be between 4 mm and 7 mm,
for example between 4.5 mm and 5.5 mm, in particular 5.1 mm.
[0033] The overall height of the sealing element can be, for
example, between 4 mm and 7 mm, for example between 4.5 mm and 6
mm, in particular 5.1 mm.
[0034] The inner bore of the sealing element can comprise, for
example, a diameter of between 3.5 mm and 5 mm, for example of 4.2
mm, and an axial height of between 2.5 mm and 5 mm, for example of
between 3.5 mm and 4 mm, in particular of 3.8 mm.
[0035] The attachment part can comprise on the connecting portion,
for example, an outer diameter of between 9 mm and 13 mm, for
example of between 10 mm and 11 mm, in particular of 10.2 mm.
[0036] The attachment part can comprise, in particular when used on
a container, an overall height (with connected break-off piece) of
between 20 mm and 40 mm, for example of between 25 mm and 35 mm, in
particular of between 28 mm and 30 mm.
[0037] The connection piece, in contrast, can comprise, on its
head, which is to be inserted into the connecting portion of the
attachment part, for example a diameter of between 7 mm and 12 mm,
for example of between 8 and 10 mm.
[0038] The overall height of the connection piece can be, for
example, between 30 mm and 50 mm, for example between 35 mm and 45
mm, in particular between 38 mm and 40 mm.
[0039] The concept underlying the invention is to be explained in
more detail below by way of the exemplary embodiments shown in the
figures, in which:
[0040] FIG. 1 shows a view of a container in the form of a pouch
having connection pieces which are provided thereon and are closed
by attachment parts;
[0041] FIG. 2A shows a side view of an attachment part;
[0042] FIG. 2B shows a sectioned view through the attachment part
according to FIG. 2A;
[0043] FIG. 3A shows a sectioned view through a sealing element
which is to be attached to the attachment part;
[0044] FIG. 3B shows an enlarged view of the sectioned view from
FIG. 3A;
[0045] FIG. 3C shows an outside view of the sealing element which
is to be attached to the attachment part;
[0046] FIG. 4 shows a side view of a connection piece, to which the
attachment part is to be attached;
[0047] FIG. 5 shows a sectioned view through the attachment part
and the connection piece in a state attached to one another;
[0048] FIG. 6 shows a sectioned view through a different exemplary
embodiment of an attachment part;
[0049] FIG. 7 shows a view of a conveying device prior to
attachment to a threaded portion of an attachment part;
[0050] FIG. 8 shows a schematic view of the attachment part with a
sealing element arranged therein after attachment of a conveying
device in the form of a syringe;
[0051] FIG. 9 shows a view of a further exemplary embodiment of a
container in the form of a pouch having connection pieces which are
arranged thereon and are closed by attachment parts; and
[0052] FIG. 10 shows an exploded view of a connection piece with an
attachment part which is to be attached thereto in the form of a
blind cap.
[0053] FIG. 1 shows a schematic view of a container 1 in the form
of a flexible pouch for storing a medical liquid, for example a
medication, a saline solution, a nutrient solution for enteral or
parenteral nutrition or the like. The pouch 1 includes a pouch body
10 which is realized for receiving the medical liquid and in a
manner known per se encloses a volume into which a medical liquid
can be filled or from which the medical liquid can be removed.
[0054] It must be pointed out at this juncture that the present
invention is not restricted to a flexible pouch, but can be
applied, in principle, to very different containers 1, in
particular also ampoules or other bottles for storing medical
liquids.
[0055] The container 1 includes two connection pieces 11, 12, which
provide the two access points into the interior of the container 1.
A first connection piece 11 is provided, in this connection, in
particular, to feed a medical liquid into the container 1, whilst a
second connection piece 12 serves for removing liquid out of the
interior of the container 1.
[0056] In the case of the exemplary embodiment shown, attachment
parts 2, 3 in the form of caps are attached to both connection
pieces 11, 12. The connection pieces 11, 12 are closed in a
liquid-tight manner to the outside by means of the attachment parts
2, 3 such that no liquid is able to pass out of the container 1 and
the container 1 is sealed to the outside against ingress of dirt or
the like.
[0057] Each attachment part 2, 3 comprises a break-off piece 20, 30
as a tamper-evident closure which can be broken off in order to
gain access to the container 1.
[0058] Whilst the attachment part 3, which is attached to the
second connection piece 12, is configured for the attachment of a
conveying device which comprises a mandrel in order to gain access
to the container 1 by piercing a sealing element by means of the
mandrel and to convey liquid out of the container 1, the first
connection piece 11 and the attachment part 2 attached thereto
provide so-called needle-free access, by means of which feeding
liquid into the container 1 or liquid out of the container 1 can be
performed without a needle using a conveying device 5 (see FIG.
7).
[0059] The container shown in FIG. 1 consists--in a manner known
per se--of flexible foils which are welded together along weld
seams 100, 101. The connection pieces 11, 12 each comprise in
particular a boat form (so-called ship shape) and are each inserted
with a widened portion 113, 121 between the foils of the container
1 and are welded with the foils in a liquid-tight manner by means
of an upper weld seam 101. Consequently, two access points to the
container 1 are created by means of the connection pieces 11, 12,
by means of which liquid can be filled into the container 1 or can
be removed out of the container 1.
[0060] An exemplary embodiment of a connector with a connection
piece 11, an attachment part 2 and a sealing element 4 which, with
the attachment part 2 attached to the connection piece 11, rests
between the attachment part 2 and the connection piece 11, are
shown in FIGS. 2A, 2B to 6.
[0061] The attachment part 2 includes a connecting portion 21, the
basic form of which is cylindrical, to which a threaded portion 22
connects, the basic form of which is also cylindrical. The
break-off piece 20 is connected integrally to the threaded portion
22, which carries threads 220 on its outer cylindrical shell
surface, a predetermined breaking point 200, which enables a
defined separation of the break-off piece 20 from the threaded
portion 22 along the predetermined breaking point 200, being
realized between the break-off piece 20 and the threaded portion
22.
[0062] The attachment part 2 is formed integrally, for example from
plastics material by means of plastics material injection
molding.
[0063] An inner opening 216, to which a conical opening 221, which
penetrates the threaded portion 22, is connected, is realized in
the connecting portion 21, the basic form of which is cylindrical.
The diameter of the opening 221 is tapered in the direction of the
inner opening 216.
[0064] The attachment part 2 can be attached to a head 110 of the
connection piece 11. This is effected by the connection piece 11
being inserted with its head 110 into the opening 216 in an
insertion direction E until a positive locking element in the form
of a circumferential ring projection 112 on the head 110 moves into
engagement in a positive locking manner with a latching engagement
210 in the form of a groove-shaped indentation inside the opening
216.
[0065] A first receiving portion 211 connects to the groove-shaped
indentation 210 inside the opening 216 in the insertion direction
E. A second receiving portion 213, which is continued in the
direction of the threaded portion 22 by a third receiving portion
215, connects, in turn, to said first receiving portion 211. In a
state in which the attachment part 2 is attached to the head 110 of
the connection piece 11, the positive locking element 112, in the
form of the circumferential ring projection, engages the latching
engagement 210, in the form of the groove-shaped indentation,
inside the opening 216 in a positive locking manner. In said state,
the head 110, by means of a toothing 111 in the form of an outer
toothing, additionally engages a toothing 212 in the form of an
inner toothing on the first receiving portion 211. The attachment
part 2 is consequently fixed in relation to the connection piece 11
both axially along the insertion direction E and non-rotatably
about the insertion direction E such that the attachment part 2 is
held on the connection piece 11 in a stationary manner.
[0066] In said attached state, the sealing element 4 lies between
the attachment part 2 and the connection piece 11, as is shown in
FIG. 5. The sealing element 4 comprises a rotationally symmetrical
or a substantially rotationally symmetrical form. It is formed by a
substantially cylindrical body 40, to which a sealing head 41
connects in the insertion direction E. A cylindrical bore 42 with a
constant diameter D3 or a form that tapers slightly toward the
sealing head 41 and is closed in a sealing manner in the insertion
direction E by the sealing head 41, is realized in the body 40 (see
for example FIGS. 3A and 3.B).
[0067] The sealing element 4 realizes a self-sealing diaphragm.
Thus, arranged in the sealing head 41 is a slot opening 410 which
penetrates the sealing head 41 axially and consequently--when a
connecting piece 51 of a conveying device 5 is attached (see FIG.
7)--opens the sealing element 4, but is closed, however, when the
conveying device 5 is not attached and consequently provides a
liquid-tight transition between the attachment part 2 and the
connection piece 11. The top side of the sealing element 4 is
situated in the interior of the opening 221. It lies beneath the
predetermined breaking point 200 and is consequently not flush with
the top side of the opening 221.
[0068] In the state attached together, the sealing element 4 rests
with its body 40 in the region of the second receiving portion 213
inside the opening 216 of the connecting portion 21, as is shown in
FIG. 5. The body 40, in this case, is inserted with radial play in
the second receiving portion 213 such that, with the conveying
device 5 not attached, the cylindrical body 40 does not contact the
extensive outer wall of the second receiving portion 213.
[0069] The second receiving portion 213 comprises a diameter D2
which is greater than the diameter D1 of the first receiving
portion 211. The sealing element 4 is inserted with its body 40
consequently with radial play in the second receiving portion 213.
A third step 219 is formed as a result between the first receiving
portion 211 and the second receiving portion 213. Space to deform
the sealing element 4 is created in this way such that the sealing
element 4 can be urged aside in a favorable manner when a conveying
device 5 is attached to the attachment part 2. The second receiving
portion 213 preferably has a diameter D2 which is greater than the
diameter D1 of the first receiving portion 211 by between 0.2 mm
and 1.5 mm.
[0070] The sealing head 41, in this connection, rests in the third
receiving portion 215 and in this way, as a result of abutment
against a first step 217 of said third receiving portion 215,
produces a sealing transition toward the attachment part 2. In
addition, the sealing head 41 and the sealing body 40 abut against
a second step 218.
[0071] In the state attached to one another, the sealing element 4
rests in a clamping manner between the attachment part 2 and the
connection piece 11. The sealing head 41, in this connection,
provides a liquid-tight separation between the conical opening 221
of the threaded portion 22 and the connection piece 11. The conical
opening 221 for receiving a conical connecting piece 51, for
example of a conveying device 5, preferably of a Luer syringe or a
Luer Lock syringe, is arranged above the sealing element 4.
[0072] As can be seen in particular from FIG. 2, both the first
receiving portion 211 and the second receiving portion 213 comprise
a toothing 212, 214 in the form of a circumferential inner
toothing. Whilst the toothing 212 of the first receiving portion
211 serves for fixing it non-rotatably on the head 110 of the
connection piece 11, the toothing 214 of the second receiving
portion 213 has no direct function in subsequent use. The toothing
214 of the second receiving portion 213 serves for removing the
attachment part 2 out of the mold in an improved manner after the
plastics material injection molding process. In the case of said
removal from the mold, the attachment part 2 is withdrawn from a
mold after the injection molding process. In order, in this
connection, to prevent, during the withdrawal, a mandrel of the
mold, which projects into the attachment part 2 and predetermines
the form of the opening 216 of the mold, from damaging the toothing
212 on the first receiving portion 211 (which could not be excluded
on account of the enlarged diameter of the second receiving portion
213), said mandrel also comprises a toothing in the region of the
second receiving portion 213 (which is also correspondingly
integrally molded on the second receiving portion 213). Because,
during removal from the mold, a toothing portion of the mandrel
which is complementary to the second receiving portion 213 is
consequently pulled out of the attachment part 2 and said toothing
portion slips through the toothing 212 of the first receiving
portion 211, damage to the toothing 212 of the first receiving
portion 211 can be reliably countered during removal from the
mold.
[0073] The sealing element 4 comprises, on a side 411 of the
sealing head 41 remote from the body 40, a flat form. The sealing
head 41 is consequently not formed in a concave manner, as has been
usual up to now, but is plane on its side 411 that faces the
threaded portion 22, which facilitates the attachment of the
conveying device 5 and the opening of the slot opening 410 during
the attachment process.
[0074] The sealing element 4, as shown in FIGS. 3A to 3C, comprises
on its body 40 a positive locking element 43 in the form of a
circumferential annulus which serves for the purpose of holding the
sealing element 4, once inserted into the opening 216, in a
positive locking manner on the attachment part 2 such that the
sealing element 4 cannot fall out of the opening 216. This
facilitates the attachment of the attachment part 2 to the assigned
connection piece 11. In particular, the attachment part 2 can be
attached to the connection piece 11 with the sealing element 4
mounted on the attachment part 2 without the sealing element 4
having to be held manually in position on the attachment part 2. In
addition, there is a, preferably circumferential, groove 44 on the
outside of the sealing element 4. In detail, the groove 44 is
arranged on the outside of the sealing body 40. The production of
the sealing element 4, for example, can be supported as a result.
The portions of the sealing body 40, which are situated above and
below the groove 44, are substantially cylindrical in this
case.
[0075] Another exemplary embodiment of a connector with an
attachment part 2 is shown in FIG. 6. In the case of the exemplary
embodiment according to FIG. 6, on the inside of the opening 221 of
the threaded portion is realized a projection 224, which extends
around the opening 221, projects radially inward into the opening
221 and forms a step against which the sealing element 4 abuts with
its outwardly pointing top side 411. On the side remote from the
top side 411, the projection 224 comprises a lead-in chamfer 223
which facilitates insertion of a connecting piece of a conveying
device and engagement in the slot opening 410 of the sealing
element. The attachment part 2 according to FIG. 6, as regards its
operation, is otherwise substantially identical to the attachment
part 2 of the exemplary embodiment according to FIGS. 2A, 2B to 5
such that reference is to be made entirely to what has been
previously described.
[0076] A conveying device 5 is attached to the attachment part 2 as
shown in FIG. 7. To attach the conveying device 5 to the attachment
part 2, first of all the break-off piece 20 on a grip element 201,
which is provided for this purpose, is gripped between two fingers
and separated from the threaded portion 22 of the attachment part 2
at its predetermined breaking point 200. Once the break-off piece
20 has been broken off, the opening 221 inside the threaded portion
22 is exposed such that the conveying device 5 can be inserted,
preferably in a sealing manner, into the opening 221 of the
threaded portion 22 by way of a connecting piece 51, the outer form
of which is conical. To connect and fix the conveying device 5 on
the attachment part 2, a connection element 50 in the form of a
union nut engages the threads 220 on the threaded portion 22 in a
screwing manner via threads 500 on the inside of the connection
element 50 such that once the connection element 50 has been
screwed onto the threaded portion 22, the conveying device 5 is
connected to the attachment part 2.
[0077] When inserting the connecting piece 51 into the opening 221
of the threaded portion 22 and when screwing the connection element
50 in the form of the union nut onto the threaded portion 22, the
connecting piece 51 moves into contact with the sealing head 41 of
the sealing element 4 and penetrates it by the connecting piece 51
piercing the slot opening 410 and urging the sealing head 41, as is
shown schematically in FIG. 8, radially aside. In this connection,
the body 40 is also deformed by being radially widened in the
second receiving portion 213.
[0078] In the position attached to the attachment part 2, the
conveying device 5 penetrates the sealing head 41 of the sealing
element 4 preferably entirely by way of its connecting piece 51, as
is shown in FIG. 8, such that a flow F between the conveying device
5 and the container 1 is created, the opening width of which flow
is not impaired by the sealing element 4.
[0079] With the conveying device 5 attached, the connecting piece
51, the form of which is realized in a conical manner, bears flatly
against the correspondingly conically formed opening 221 of the
threaded portion 22 such that it seals the transition between the
conveying device 5 and the attachment part 2.
[0080] The sealing element 4 can be produced from a thermoplastic
elastomer and can preferably comprise a Shore Hardness of between
25 and 70, for example of between 30 and 60. Because the sealing
element 4 is configured in a comparatively rigid manner in said
configuration, the conveying device 5 can urge the sealing element
4 efficiently radially aside by way of its connecting piece 51, in
particular without the sealing element 4 stretching axially. The
greater degree of hardness of the sealing element 4--compared to
sealing elements used hitherto--can consequently facilitate the
attaching of the conveying device 5 to the attachment part 2 and
improve the creating of a flow F with a large flow diameter. In an
alternative embodiment, the sealing element 4 can be produced from
polyisoprene.
[0081] After conveying a medical liquid out of a syringe body 52 of
the syringe 5 into the container 1, the conveying device 5 can be
removed from the attachment part 2 again by the connection element
50 being released and the conveying device 5 removed from the
attachment part 2. This means that the connecting piece 51 is
disengaged from the slot opening 410, as a result of which the slot
opening 410 closes again automatically and the sealing element 4
consequently returns into its initial state.
[0082] A further exemplary embodiment of a container 1 is shown in
FIGS. 9 and 10.
[0083] In the case of the exemplary embodiment according to FIGS. 9
and 10, the container 1 is once again configured as a flexible
pouch which is formed from flexible foils. The foils are welded
together by means of weld seams 100, 101, connection pieces 11, 12
of two connectors being inserted with portions 113, 121 between the
foils of the pouch and being welded with the foils in a
liquid-tight manner by means of an upper weld seam 101.
[0084] Two connectors, via which access points to the container 1
are created, are provided by means of the connection pieces 11,
12.
[0085] In the case of the exemplary embodiment shown, the one
connection piece 11 is connected to an attachment part 2, as has
been described previously by way of the exemplary embodiment
according to FIGS. 2A, 2B to 5. With reference to said connector,
reference is consequently to be made entirely to what has
previously been described.
[0086] The other connection piece 12, in contrast, in the case of
the exemplary embodiment, is connected to an attachment part 3 in
the form of a so-called blind cap, by means of which the connection
piece 12, when the container 1 is used subsequently, is fixedly
closed such that a user cannot easily access the container 1 by
means of the connection piece 12.
[0087] The container 1 of the exemplary embodiment according to
FIGS. 9 and 10 can be used, in particular, for dialysis and/or
transfusion. During production of the pouch, it is filled by means
of the connection piece 12, the blind cap 3 being attached to the
connection piece 12 and the connection piece 12 consequently being
closed directly after filling. In subsequent operation, the
container 1 can then be accessed by means of the other connection
piece 11 in order to remove liquid out of the container 1 or to
feed it to the container 1.
[0088] The connector, which is formed by the blind cap 3 and the
connection piece 12, is shown in an exploded view in FIG. 10. The
connection piece 12 comprises a head 120, to which the blind cap 3
can be attached for closing the connection piece 12. A sealing
element 6, which ensures a liquid-tight closure of the connection
piece 12 and is received in the interior of the blind cap 3, is
used in this connection between the blind cap 3 and the head 120 of
the connection piece 12. With the blind cap 3 attached, the sealing
element 6 is held in a clamping manner between the blind cap 3 and
the head 120 such that the connection piece 12 is closed in a
liquid-tight manner in this way.
[0089] The blind cap 3 serves for the purpose of preventing the use
of the connector, which is provided by the connection piece 12,
when the container 1 is used subsequently. The blind cap 3 cannot
easily be removed by a user and is to remain on the connection
piece 12 when the container 1 is used subsequently.
[0090] When the container 1 is used subsequently, the connection
piece 11 is able to be accessed, in contrast, by the break-off
piece 20 being broken off in exactly the same way as has been
described previously. A conveying device 5, for example in the form
of a syringe or a pump, for example a transfusion pump, can be
attached to the attachment part 2 in order to fill liquid into the
container 1 or to remove it out of the container 1.
[0091] To produce the container 1, first of all the flexible foils,
which realize the container 1, are rolled out, laid one on top of
the other and are, for example, printed. The weld seams 100 are
then applied at the sides and at the lower edge of the container 1
such that the foils are tightly connected together at their side
edges and at the bottom. The foils are then cut such that the pouch
form shown in FIG. 9 is produced.
[0092] An opening is then applied in the region of the lower weld
seam 100 as suspending means for the container 1.
[0093] The foils of the container 1 which are laid one on top of
the other are then separated from one another at their upper edge,
and the connection pieces 11, 12 are inserted with their portions
113, 121 between the foils. The connection piece 11, in this
connection, is inserted with the attachment part 2 attached
thereto. The connection piece 12, in contrast, is set between the
foils without a blind cap 3.
[0094] If the connection pieces 11, 12 have been inserted between
the foils, the upper weld seam 101 is applied in order to weld the
foils together and to the connection pieces 11, 12 in this way. The
pouch interior is closed in a liquid-tight manner in this way.
Access points are provided by means of the connection pieces 11,
12.
[0095] The container 1 is then filled by means of the connection
piece 12, for example with a saline solution or another medical
liquid. Once the filling has been completed, the blind cap 3 is
attached to the connection piece 12 with the sealing element 6 in
order to close the connection piece 12 in this way. Because the
attachment part 2 is also attached to the other connection piece
11, the container 1 is consequently closed in a liquid-tight
manner.
[0096] In order to deliver the container 1 for further use, the
container 1 is then shrink-wrapped into an additional wrapping by
the container 1 being placed between foils and said foils being
welded together.
[0097] The container 1, in the shrink-wrapped form, can then be
sterilized, for example, and, for example, packed in a box.
[0098] For actual use, for example in a hospital, the container 1
is then removed out of the box and the foil wrapping is removed by
pulling off the foils. The container 1 can be accessed via the
connector of the connection piece 11 which provides a Luer Lock
port in order, for example, to remove liquid out of the container 1
so as to flush the transfusion set and/or to infuse a patient.
[0099] The concept underlying the invention is not limited to the
previously depicted exemplary embodiments, but can also be
realized, in principle, with completely different embodiments.
[0100] In particular, the present invention can also be used in the
case of other containers in the form of ampoules or bottles or the
like.
[0101] In principle, such a container can comprise one or multiple
connection pieces with one or multiple similar or different
attachment parts to be arranged thereon.
LIST OF REFERENCES
[0102] 1 Pouch [0103] 10 Pouch body [0104] 100, 101 Weld seam
[0105] 11, 12 Connection piece [0106] 110 Head [0107] 111 Toothing
[0108] 112 Positive locking element (ring projection) [0109] 113
Portion [0110] 120 Portion [0111] 2 Attachment part [0112] 20
Break-off part [0113] 200 Predetermined breaking point [0114] 201
Grip element [0115] 21 Connection portion [0116] 210 Latching
engagement [0117] 211 Receiving portion [0118] 212 Toothing [0119]
213 Receiving portion [0120] 214 Toothing [0121] 215 Receiving
portion [0122] 216 Opening [0123] 217 First step [0124] 218 Second
step [0125] 218 Third step [0126] 22 Threaded portion [0127] 220
Thread [0128] 221 Opening [0129] 223 Lead-in chamfer [0130] 224
Projection [0131] 3 Attachment part [0132] 30 Break-off piece
[0133] 4 Sealing element [0134] 40 Body [0135] 41 Sealing head
[0136] 410 Slot opening [0137] 411 Side [0138] 42 Interior [0139]
43 Annulus [0140] 44 Groove or indentation [0141] 5 Conveying
device (syringe) [0142] 50 Connection element [0143] 500 Thread
[0144] 51 Connecting piece (syringe cone) [0145] 52 Syringe body
[0146] 6 Sealing element [0147] D1, D2, D3 Diameter [0148] E
Insertion direction [0149] F Flow direction
* * * * *